Onsite Sterility Assurance Manager — GMP/Aseptic Leader

ThermoFisher Scientific; Plainville (MA); On-site; USD 103,000 - 155,000; Full time

Benefits offered by this job

Healthcare

Annual incentive plan bonus

PTO and holidays

Parental leave

Stock Purchase Plan

Retirement savings plan

Job summary

Thermo Fisher Scientific in Massachusetts is seeking a Sterility Assurance Manager to lead aseptic processing and contamination control across a sterile fill/finish facility. You will drive GMP compliance with FDA/EU Annex 1 and act as SME during regulatory inspections.

The role requires 7–10 years in sterile pharma manufacturing, strong communication skills, and a track record of continuous improvement in aseptic operations. This onsite position offers competitive compensation and benefits.

Qualifications

• Bachelor’s degree in Microbiology or related field.
• 7–10 years of experience in sterile/pharma manufacturing or aseptic operations.
• Strong knowledge of GMP regulations (FDA, EU Annex 1).

Responsibilities

• Promote understanding of aseptic processes and related regulations.
• Conduct GEMBA assessments of aseptic processes on site.
• Define and improve EM and Contamination Control programs.
• Assist with microbiological and sterility risk assessments for changes, deviations, and CAPAs.
• Serve as SME during regulatory inspections and audits regarding aseptic processing and contamination control.
• Present aseptic observation program data to site and executive leadership in management review forums.
• Collaborates with manufacturing, microbiology, and QC as the site steward of the Contamination Control Strategy (CCS).
• Supports qualification and validation of equipment, utilities (e.g. HVAC, WFI), and fill/finish equipment.
• Lead continuous improvement projects related to aseptic behavior, risk mitigation, and cleanroom operations.

Skills

GMP regulations

Regulatory inspections

Aseptic processing

Communication skills

Analytical problem-solving

Leadership

Education

Bachelor’s degree in Microbiology or related field

Job description

Thermo Fisher Scientific in Massachusetts is seeking a Sterility Assurance Manager to lead aseptic processing and contamination control across a sterile fill/finish facility. You will drive GMP compliance with FDA/EU Annex 1 and act as SME during regulatory inspections.

The role requires 7–10 years in sterile pharma manufacturing, strong communication skills, and a track record of continuous improvement in aseptic operations. This onsite position offers competitive compensation and benefits.